Summary

The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of
the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal
angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.

Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon

Primary Outcomes

Measure

Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative (≤30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 12 Months.

time frame:
12 months

Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year.

Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 1 Month: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 1 Month.

time frame:
1 Month

Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 6 Months: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death.

time frame:
6 Months

Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month.

time frame:
1 month

Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months.

time frame:
6 Months

Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months.

Eligibility Criteria

Male or female participants at least 18 years old.

Clinical Inclusion Criteria:
1. Male or non-pregnant female ≥18 years of age;
2. Rutherford Clinical Category 2-4;
3. Patient is willing to provide informed consent, is geographically stable and comply
with the required follow up visits, testing schedule and medication regimen;
Angiographic Lesion Inclusion Criteria:
4. Length ≤15 cm;
5. Up to two focal lesions or segments within the designated 15 cm length of vessel may
be treated (e.g. two discrete segments, separated by several cm, but both falling
within a composite length of <15 cm);
6. ≥70% stenosis by visual estimate;
7. Lesion location starts ≥1 cm below the common femoral bifurcation and terminates
distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
8. de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty
procedure;
9. Lesion is located at least 3 cm from any stent, if target vessel was previously
stented;
10. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available
device size matrix;
11. Successful, uncomplicated (without use of a crossing device) antegrade wire crossing
of lesion;
12. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by
angiography (treatment of target lesion acceptable after successful treatment of
inflow artery lesions); NOTE: Successful inflow artery treatment is defined as
attainment of residual diameter stenosis ≤30% without death or major vascular
complication.
13. At least one patent native outflow artery to the ankle, free from significant (≥50%)
stenosis as confirmed by angiography that has not previously been revascularized
(treatment of outflow disease is NOT permitted during the index procedure);
14. Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned
30 days after the protocol treatment in order to avoid confounding complications;
15. No other prior vascular interventions within 2 weeks before and/or planned 30 days
after the protocol treatment.
Exclusion Criteria:
Patients will be excluded if ANY of the following conditions apply:
1. Pregnant or planning on becoming pregnant or men intending to father children;
2. Life expectancy of <5 years;
3. Patient is currently participating in an investigational drug or other device study
or previously enrolled in this study; NOTE: Enrollment in another clinical trial
during the follow up period is not allowed.
4. History of hemorrhagic stroke within 3 months;
5. Previous or planned surgical or interventional procedure within 2 weeks before or
within 30 days after the index procedure;
6. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of
enrollment;
7. Rutherford Class 0, 1, 5 or 6;
8. Renal failure or chronic kidney disease with modification in diet in renal disease
glomerular filtration rate (MDRD GFR) ≤30 ml/min per 1.73 m2 (or serum creatinine
≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
9. Prior vascular surgery of the index limb, with the exception of remote common femoral
patch angioplasty separated by at least 2 cm from the target lesion;
10. Inability to take required study medications or allergy to contrast that cannot be
adequately managed with pre- and post-procedure medication;
11. Anticipated use of IIb/IIIa inhibitor prior to randomization;
12. Ipsilateral retrograde access;
13. Composite lesion length is >15 cm or there is no normal proximal arterial segment in
which duplex flow velocity can be measured;
14. Significant inflow disease. Successful treatment of inflow disease allowed prior to
target lesion treatment;
15. Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three
tibial vessels), or planned future treatment of vascular disease distal to the target
lesion;
16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in
target vessel;
17. Severe calcification that renders the lesion un-dilatable;
18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty,
scoring/cutting balloon, etc.).

The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of
obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries up
to 15 cm in length and ≥4.0 to ≤6.0 mm in diameter. This study will randomize approximately
476 patients who will receive either the Moxy balloon or standard balloon angioplasty at 55
global investigational sites. Subjects will be blinded to treatment until 12 months and will
participate in long term follow-up for 5 years.

Trial information was received from ClinicalTrials.gov and was last updated in March 2016.